Studies of the Toxicological Potential of Capsinoids: IV. Teratology Studies of CH-19 Sweet Extract in Rats and Rabbits

Bernard, Bruce K.; Watanabe, Eri; Kodama, Terutaka; Tsubuku, Shoji; Otabe, Akira; Katsumata, Yoshihiro; Matsuoka, Tetsuya; Masuyama, Takeshi

doi:10.1080/10915810802513502

Cited by 13 publications

(17 citation statements)

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“…Dihydrocapsiate (80.75 mg/kg/day) was administered as part of the CH-19 Sweet extract (5 ml/kg/day) employed as the high dose in a two-generation reproduction study (Kodama et al 2008a) and a teratology study (Bernard et al 2008b), both in rats. In the reproduction study, dihydrocapsiate administration was started 8 weeks before the start of mating for F o males, 2 weeks before the start of mating for F o females, and on the day of weaning (day 21 after birth) for F, rats.…”

Section: Discussionmentioning

confidence: 99%

Studies of the Toxicological Potential of Capsinoids: V. Genotoxicity Studies of Dihydrocapsiate

et al. 2008

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A series of studies was performed to evaluate the safety of dihydrocapsiate (4-hydroxy-3-methoxybenzyl 8-methylnonanoate; CAS no. 205687-03-2). This study evaluated the potential genotoxicity of this compound using a variety of in vitro and in vivo test systems, including bacterial reverse mutation test, chromosomal aberration test, micronucleus test, gene mutation assay with transgenic rats, and single-cell gel (SCG) assay (Comet assay). In vitro tests (bacterial reverse mutation test and chromosomal aberration test) produced positive results in the absence of metabolic activation, but negative results in the presence of metabolic activation. The in vivo gene mutation assay (with transgenic rats) produced negative results, as did the in vivo mouse micronucleus assay, which failed to induce micronucleated polychromatic erythrocytes. Although the rat SCG assay produced statistically significant increases in the Olive tail moment and % tail DNA of the liver and intestine in the 2000 mg/kg group (compared with the negative-control group), a number of factors caused the authors to question the validity of these findings. Taken together, these results suggest that dihydrocapsiate has a low or extremely low likelihood of inducing genotoxicity.

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Section: Discussionmentioning

confidence: 99%

Studies of the Toxicological Potential of Capsinoids: V. Genotoxicity Studies of Dihydrocapsiate

et al. 2008

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“…The authors concluded the NOAEL of dihydrocapsiate for general toxicity in dams, reproductive functions of dams, and embryofetal development was judged to be 1000 mg/kg/day both in rats and rabbits. Bernard et al (2008a) performed a similar study using CH-19 Sweet extract using the same test subjects and days of and route of test article administration. The dose levels employed were 0 (vehicle), 1.25, 2.5, and 5.0 ml/kg in the rat and 0 (vehicle), 0.25, 0.5, and 1.0 ml/kg in the rabbit.…”

Section: Malesmentioning

confidence: 99%

Studies of the Toxicological Potential of Capsinoids: VII. A 13-Week Toxicity Study of Dihydrocapsiate in Rats

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To evaluate the safety of dihydrocapsiate (4-hydroxy-3-methoxybenzyl 8-methylnonanoate; CAS No. 205687-03-2), a 13-week gavage toxicity study was conducted in Sprague-Dawley rats (10/sex/group). Test subjects received either dihydrocapsiate, 100, 300, or 1000 mg/kg/day, or vehicle by gavage and were observed for antemortem and postmortem signs of toxicity, which included changes in clinical signs, body weights, food consumption, water intake, ophthalmology, clinical pathology (clinical chemistry, hematology, urinalysis), tissue findings (macroscopic and microscopic examination), as well as organ weights. No changes attributable to the test article were observed in clinical signs, body weights, food consumption, water intake, ophthalmology, urinalysis, hematology, or histopathology. A number of sporadic blood chemistry differences were observed at the high dose between treated and controls, but were not of toxicological significance and were not attributable to the test article. These included increased alanine aminotransferase (ALT) activity in males; increased total protein in males and females; increased calcium, percentage of albumin fraction, and A/G (albumin/globulin) ratio and decreased percentage of gamma-globulin fraction in female rats. An effect, which was attributable to the test article, was increases in both absolute and relative liver weights in the high dose (both sexes). In the absence of histopathological changes attributable to the test article, the liver weight changes were considered adaptive (physiological) in nature and not of toxicological significance. It was concluded that the no observed adverse effect level (NOAEL) of dihydrocapsiate was 1000 mg/kg/day for both male and female rats in this 13-week gavage study.

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“…This same amount of dihydrocapsiate (81 mg/kg/day) was administered as part of the CH-19 Sweet extract (5 nil/kg/day) employed as high doses in a two-generation reproduction study (Kodama et al 2008a) and a teratology study (Bernard et al 2008), both in rats. In the reproduction study, dihydrocapsiate administration was started 8 weeks before the start of mating…”

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confidence: 99%

Studies of the Toxicological Potential of Capsinoids: VIII. A 13-Week Toxicity Study of Commercial-Grade Dihydrocapsiate in Rats

et al. 2008

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Dihydrocapsiate, (4-hydroxy-3-methoxybenzyl 8-methylnona- noate; CAS No. 205687-03-2) is a naturally occurring capsinoid compound found in nonpungent chili peppers. Although the safety of synthetically produced dihydrocapsiate has been previously evaluated, the purpose of this 13-week gavage toxicity study is to evaluate dihydrocapsiate produced with a slightly modified manufacturing process. Sprague-Dawley rats, 10 rats/sex/group, 6 weeks of age at study initiation, were administered the dihydrocapsiate daily by gavage at dose levels of 0 (vehicle), 100, 300, or 1000 mg/kg/day. The rats were observed for antimortem and postmortem signs of toxicity, including changes in clinical signs, body weights, food consumption, water intake, ophthalmology, clinical pathology (clinical chemistry, hematology, urinalysis), tissue findings (macroscopic and microscopic examination), as well as organ weights. There were no changes observed in clinical signs, body weight, food consumption, water intake, ophthalmology, urinalysis, hematology, or blood chemistry that were attributable to the administration of dihydrocapsiate. The only change observed attributable to the dihydrocapsiate administration involved the liver and that change occurred only at the high dose (1000 mg/kg). Both sexes had an increase in organ weights, but this increase correlated with a change in histopathology (i.e., hepatocyte hypertrophy) only in the males. No dihydrocapsiate-related histopathological changes were observed in males at doses < or = 300 mg/kg or in females at any of the doses tested (< or = 1000 mg/kg). It was concluded that the no observed adverse effect level (NOAEL) of dihydrocapsiate was 300 mg/kg/day for male rats and 1000 mg/kg/day for female rats in this 13 week gavage study.

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Studies of the Toxicological Potential of Capsinoids: IV. Teratology Studies of CH-19 Sweet Extract in Rats and Rabbits

Cited by 13 publications

References 13 publications

Studies of the Toxicological Potential of Capsinoids: V. Genotoxicity Studies of Dihydrocapsiate

Studies of the Toxicological Potential of Capsinoids: V. Genotoxicity Studies of Dihydrocapsiate

Studies of the Toxicological Potential of Capsinoids: VII. A 13-Week Toxicity Study of Dihydrocapsiate in Rats

Studies of the Toxicological Potential of Capsinoids: VIII. A 13-Week Toxicity Study of Commercial-Grade Dihydrocapsiate in Rats

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